The virtual trial, being conducted under an investigational new drug (IND) application using electronic tools, allows patients to participate in the clinical trial regardless of their proximity to clinical sites.
Pfizer and its research partners hope to determine if the results of the pilot REMOTE virtual trial can replicate the results of a previously completed Phase IV Detrol LA trial, and in this way begin to validate virtual, patient-centered approaches to clinical research.
Further, the company is planning to recruit around 600 patients in the trial across 10 states of the US.
Pfizer executive vice president and chief medical officer Freda Lewis-Hall said with the REMOTE virtual trial pilot, for the first time they can make it possible for patients to participate in clinical trials without having to visit physical sites.
FDA Center for Drug Evaluation and Research director Janet Woodcock said they commend Pfizer’s progress on the REMOTE pilot and encourage all manufacturers considering other novel ideas in advancing clinical trials to have prospective discussions with the Agency regarding trial design and oversight.